GlobeNewswire Inc | Nov 18, 2020 01:12PM EST

November 18, 2020

European Commission approves Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older

-- First and only recombinant influenza vaccine approved in the European Union -- Contains three times more antigen than standard-dose vaccines -- Phase 3 efficacy trial demonstrated improved protection against influenza compared to standard-dose influenza vaccine, and reduced the risk of influenza by an additional 30% in adults aged 50 years and older1,2

PARIS November 18, 2020 The European Commission has granted a marketing authorization for Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine, for the prevention of influenza in adults aged 18 years and older. Supemtek is the first and only recombinant influenza vaccine now approved in the European Union.

Supemtek is produced using recombinant technology, which allows an exact match to the key component of the influenza strains recommended by the World Health Organization, avoiding the risk of viral mutations. Supemtek also contains three times more antigen than both egg-based and cell-based standard-dose vaccines. This increased amount of antigen and the use of recombinant technology provide improved protection against influenza, particularly in those aged 50 and older. In comparison with a standard-dose egg-based quadrivalent influenza vaccine, Supemtek reduced the risk of influenza by an additional 30% for adults aged 50 years and older1,2.

The authorization is based on clinical data demonstrating safety, immunogenicity and efficacy of Supemtek in two Phase 3 randomized controlled trials1,2 involving more than 10,000 patients in total. Specifically, the relative efficacy of Supemtek was demonstrated in a Phase 3 multicenter (40 outpatient centers in the US, involving more than 9,000 adults), randomized controlled efficacy trial1,2.

In the context of the COVID-19 pandemic, preventing influenza remains a public health priority, said Thomas Triomphe, Head of Sanofi Pasteur. Todays approval of Supemtek supports our strong commitment in advancing influenza vaccine technology. With Supemtek, we provide European health authorities with an additional innovative solution that has demonstrated increased ability to prevent influenza and its potentially severe complications, as well as the burden this causes on healthcare systems.

Each year, influenza-associated deaths range from 290,000 to 650,0003,4 globally, and the burden on hospitals is around 10 million of influenza-related hospitalizations5. Recent data also show that influenza can multiply the risk of heart attack by up to 10 times, and the risk of stroke by up to 8 times, in the week after influenza infection6 demonstrating that the burden of influenza goes beyond its well-known respiratory complications.

The first European launches are expected for the 2022/2023 influenza season, with a possibility of accelerating the availability of doses as early as the 2021/2022 season in certain countries. Outside of the EU, Supemtek is also approved in the U.S. under the tradename Flublok Quadrivalent.About the recombinant technology

The recombinant technology is a new way of producing influenza vaccines which differs significantly from the two other technologies currently in use (egg-based and cell-based technologies) as it avoids the risk of viral mutations that can lower vaccine efficacy. It ensures the exact match to the key component of the influenza strains recommended by the World Health Organization every year for producing influenza vaccines.

In an independent systematic review7 published in October 2020, the European Center for Disease Prevention notes that the recombinant haemagglutinin was found to provide a greater protective effect against overall influenza compared with no vaccination and with traditional influenza vaccination [] this effect may be attributable to either the restriction of mutations seen with egg-based vaccines or the higher dose of antigen seen in this type of influenza vaccine.

The recombinant technology is also used for the development of one of Sanofis vaccines against COVID-19, developed in partnership with GSK and with the support of US Biomedical Advanced Research and Development Authority (BARDA). The Companies announced the start of the Phase 1/2 clinical trial for their adjuvanted recombinant COVID-19 vaccine candidate in September and anticipate first results in December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, Sanofi and GSK plan to request regulatory approval in the first half of 2021.

Increased production of seasonal influenza vaccines in the unique context of the COVID-19 pandemic

As the leading manufacturer of influenza vaccines, Sanofi Pasteur, the vaccines global business unit of Sanofi, is supporting health authorities in their efforts to strengthen influenza vaccination campaigns in the unique context of COVID-19. For the 2020/2021 influenza season, the Company is delivering globally 20% more doses of flu vaccines, reaching an unprecedented production level of 250 million doses, across its influenza vaccine portfolio which includes a wide range of vaccines (standard doses and differentiated vaccines) that are proven to protect people of all ages from the risks of influenza.



About Sanofi

Sanofi is dedicated to supporting people through their health challenges. Weare a global biopharmaceutical company focused on human health. We preventillness with vaccines, provide innovative treatments to fight pain and easesuffering. We stand by the few who suffer from rare diseases and the millionswith long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transformingscientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life



Investor Relations Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton

Media Relations ContactNicolas Kressmann Investor Relations Contacts North AmericaTel.: +1 (732) 532-5318 Felix LauscherNicolas.Kressmann@sanofi.com Fara Berkowitz Suzanne Greco



IR main line: Tel.: +33 (0)1 53 77 45 45 investor.relations@sanofi.com



Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude projections and estimates regarding the marketing and other potentialof the product, or regarding potential future revenues from the product.Forward-looking statements are generally identified by the words ?expects?,?anticipates?, ?believes?, ?intends?, ?estimates?, ?plans? and similarexpressions. Although Sanofi?s management believes that the expectationsreflected in such forward-looking statements are reasonable, investors arecautioned that forward-looking information and statements are subject tovarious risks and uncertainties, many of which are difficult to predict andgenerally beyond the control of Sanofi, that could cause actual results anddevelopments to differ materially from those expressed in, or implied orprojected by, the forward-looking information and statements. These risks anduncertainties include among other things, unexpected regulatory actions ordelays, or government regulation generally, that could affect the availabilityor commercial potential of the product, the fact that product may not becommercially successful, the uncertainties inherent in research anddevelopment, including future clinical data and analysis of existing clinicaldata relating to the product, including post marketing, unexpected safety,quality or manufacturing issues, competition in general, risks associated withintellectual property and any related future litigation and the ultimateoutcome of such litigation, and volatile economic and market conditions, andthe impact that COVID-19 will have on us, our customers, suppliers, vendors,and other business partners, and the financial condition of any one of them, aswell as on our employees and on the global economy as a whole. Any materialeffect of COVID-19 on any of the foregoing could also adversely impact us. Thissituation is changing rapidly and additional impacts may arise of which we arenot currently aware and may exacerbate other previously identified risks. Therisks and uncertainties also include the uncertainties discussed or identifiedin the public filings with the SEC and the AMF made by Sanofi, including thoselisted under ?Risk Factors? and ?Cautionary Statement Regarding Forward-LookingStatements? in Sanofi?s annual report on Form 20-F for the year ended December31, 2019. Other than as required by applicable law, Sanofi does not undertakeany obligation to update or revise any forward-looking information orstatements.



1Dunkle LM, Izikson R, Patriarca P, et al. 20172Dunkle LM, Izikson R, et al. 2017a3Centers for Disease Control and Prevention. Flu symptoms and complications4WHO factsheet5 Lancet Respir Med 2019; 7: 69896Warren-Gash C, et al. Eur Respir J. 2018:517Systematic review of the efficacy, effectiveness and safety of newer and enhanced seasonal influenza vaccines. ECDC. Oct 2020



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